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Completed

NCT Number: NCT00282516

Asthma In-Home Monitoring (AIM) Trial

OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.

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Key information

About this study

OBJECTIVE: Determine whether home asthma telemonitoring using store-and-forward technology improves outcomes when compared to in-person, office-based visits.

METHODS: 120 patients 6-17 yrs with persistent asthma were randomized into two groups: office or virtual. Both groups followed the same ambulatory clinical pathway for 12 months. Office patients received traditional in-person education and case management. Virtual patients received computers, Internet connection, and in-home Web-based case management and received education via the study web site. They also recorded and forwarded a video of peak flow and inhaler use to their case manager two times a week for 6 weeks then once a week thereafter and submitted daily asthma diaries electronically via the web site. Virtual patients were seen in-person only 3 times. Regimen adherence was assessed by monitoring therapeutic (controller medication use, video medication use) and diagnostic (asthma symptom diary and peak flow submitted electronically) outcomes. Disease control outcome measures included quality of life, utilization of services, and symptom control.

RESULTS: 120 volunteers (45 females) were enrolled. The groups were clinically comparable: office 22 females, 38 males 9.0 + 3.0 yrs (mean + SD) virtual 23 females, 37 males, 10.2 + 3.1 yrs. Virtual patients had higher metered-dose inhaler/valved holding chamber score than the office group at 52 weeks (94% vs 89%, p < 0.05), a higher adherence to daily asthma symptom diary submission (35.4% vs 20.8 %, p < 0.01), less participant time (636 vs 713 patient months, p < 0.05), and were older (10.2 + 3.1 years virtual, 9.0 + 3.0 office, p < 0.05). Caregivers in both groups perceived an increase in quality of life (p<0.05) and an increase in asthma knowledge scores from baseline (p < 0.01). There were no other outcome differences in therapeutic or disease control or outcome measures.

CONCLUSION: Virtual patients achieved excellent asthma therapeutic and disease control outcomes. When compared to idealized office-based care they were more adherent to diary submission and had better inhaler scores at 52 weeks than office-based patients. Store-and-forward telemedicine technology and case management provides an additional tool to assist in the management of children with persistent asthma.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of persistent asthma as defined using the NHLBI Expert Panel Report -2 guidelines Assignment of severity classification will be made at the beginning of the study based on severity of disease off therapy.
  • Dependent of active duty or retired US military personnel
  • 6 to 17 years of age
  • Not moving from Oahu for 12 months after entry into study
  • Ability to receive cable modem hook-up in home
  • Willingness to learn to record and send MDI + spacer technique and peak flow two times week
  • Willing to attend asthma education follow-up visits either in person or electronically at 2- weeks, 6- weeks, 3-months and 6-month intervals after initiation into the study.
  • Willing to complete survey at the end of study period.
  • Willing to sign informed, written consent

Exclusion criteria

  • Diagnosis of mild intermittent asthma as defined by Expert Panel Report -2 guidelines.
  • <6 and >17 years of age
  • Family leaving Oahu within 12 months
  • Inability to receive cable modem hook-up in home
  • Unwilling or unable to learn to record and send MDI + spacer technique and peak flow and/or to attend asthma education follow-up visits either in person or electronically at initiation into study and at 2- weeks, 6- weeks, 3-months and 6 month intervals.
  • Unwilling to complete survey at the end of study period.
  • Patients or parents who decline to participate.
  • Patients with other chronic pulmonary disease (cystic fibrosis, bronchopulmonary dysplasia)

Treatment and study plan

In-home telemonitoring of pediatric patients with persistent asthma

Procedure

Sponsors and collaborators

Lead sponsor

Tripler Army Medical Center

Fed

Collaborators

  • U.S. Army Medical Research Acquisition Activity

Registry information

Official study title

"Internet-based Home Monitoring and Education of Children With Asthma is Comparable to Ideal, Office-based Care: Results of a One-year, Asthma In-Home Monitoring (AIM) Trial"

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jan 26, 2006
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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